(1) The application for a license for a clinical laboratory shall be made on forms provided by the Department of Human Services and shall be executed by the owner or one of the owners or by an officer of the firm or corporation owning the clinical laboratory, or in the case of a county or municipality, by the public official responsible for operation of the laboratory, or in the case of an institution, by the administrator of the institution. The application shall contain the names of the owner, the director or directors of the clinical laboratory, the location and physical description of the clinical laboratory, the laboratory specialties for which a license is requested and such other information as the department may require.
(2)(a) The application shall be accompanied by an annual or biennial license fee to be established by the department. The fee shall be based on test volume, test complexity, the number of specialties performed and private laboratory accreditation. For each level of laboratory testing, the fee shall be not more than 100 percent of the corresponding fee charged by the federal laboratory certification program known as the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a) in effect on July 1, 1999. The fee for substance of abuse screening laboratories not certified under the Clinical Laboratory Improvement Amendments of 1988 shall be comparable to the clinical laboratory fee established under this section.
(b) The department may establish prorated fees for licenses issued for a year or less and when there is a change in the laboratory’s owner, director or address. A prorated license fee shall be issued to a laboratory accredited by an organization recognized by the department.
(3) Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the one-year or two-year cycle following the date of issuance or on such date as may be specified by department rule. Licenses issued under this section shall be renewable in the manner prescribed by the department.
(4) Subject to prior approval of the Oregon Department of Administrative Services and a report to the Emergency Board prior to adopting the fees and charges, the fees and charges established under this section shall not exceed the cost of administering the regulatory program of the Department of Human Services pertaining to the purpose for which the fee or charge is established, as authorized by the Legislative Assembly within the department’s budget, as the budget may be modified by the Emergency Board. [1969 c.685 §7; 1977 c.284 §3; 1979 c.696 §2; 1989 c.776 §5; 1991 c.703 §6; 1993 c.109 §7; 1999 c.341 §§5,6; 2007 c.768 §4]
Section: Previous 438.040 438.050 438.055 438.060 438.070 438.110 438.120 438.130 438.140 438.150 438.160 438.210 438.220 438.310 438.320 NextLast modified: August 7, 2008